Duns Number:021315587
Device Description: Full Shape II system with paramagnetic analyzer
Catalog Number
-
Brand Name
Shape Vital Sign System
Version/Model Number
0008-3012
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150888
Product Code
BTY
Product Code Name
Calculator, Predicted Values, Pulmonary Function
Public Device Record Key
6a97bbea-7950-4612-bacf-2fab44745881
Public Version Date
April 15, 2022
Public Version Number
3
DI Record Publish Date
May 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |